A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide (Monofer®) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia - Iron Ologisaccharide to patients with IBD and iron deficiency anaemia

• Conditions: Inflammatory bowel disease subjects with iron deficiency anaemia; MedDRA version: 14.0Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 14.0Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2009-012544-16-HU
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-05
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria:
1. Men and women, aged more than 18 years.
2. Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn’s disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis).
3. Hb <12.0 g/dL (7.45 mmol/L).
4. Transferrin saturation (TfS) <20 %.
5. Life expectancy beyond 12 months.
6. Willingness to participate after informed consent.
(Serum ferritin has been chosen not to be inclusion criteria as the cut-off level is highly dependent upon the disease).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Anaemia predominantly caused by other factors than iron deficiency anaemia.
2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate).
4. Known hypersensitivity to any excipients in the investigational drug products.
5. Subjects with a history of multiple allergies.
6. Active Intestinal Tuberculosis.
7. Active Intestinal amoebic infections.
8. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper limit normal).
9. Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive protein (CRP)).
10. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
11. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches.
12. Extensive active bleeding necessitating blood transfusion.
13. Planned elective surgery during the study.
14. Participation in any other clinical study within 3 months prior to screening.
15. Intolerance to oral iron treatment.
16. Untreated B12 or folate deficiency.
17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
18. Erythrypoietin treatment within 8 weeks prior to screening visit.
19. Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test.
20. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
21. History of immunocompromise, including positive HIV test result.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that intravenous iron oligosaccharides is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to IBD, evaluated as the ability to increase haemoglobin (Hb).;Secondary Objective: The secondary objectives of the study are:<br>1. To assess other relevant haematology and biochemical parameters during the study.<br>2. Quality of Life assessment by questionnaire.<br>3. To assess safety of intravenous iron oligosaccharide compared to oral iron sulfate.<br>4. Assessment of RLS symptoms and change in these symptoms during the study.;Primary end point(s): The primary endpoint of the present study is change in Hb concentration from baseline to week 8.